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Egg-Banking and Ovo-donation

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00785993
First received: November 4, 2008
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

Egg-banking would considerably simplify the logistics and means by which oocytes could be donated. These banks would make it easier to immediately provide oocytes that would be compatible to the recipient, shortening or even eliminating the problem of long waiting lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically diminishing the risk of transmission of infectious diseases in a fashion analogous to semen banks. The most essential prerequisite for a successful egg cryo-banking program is to have an efficient oocyte cryopreservation technology. Recent studies, including our own experience, have indicated that vitrified oocytes preserve intact their potential to fertilize and further develop into competent embryos, giving high clinical results as well as high survival rates. The aim of this study is to evaluate impact of the establishment of an egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes. Recipients are allocated randomly into each group ("fresh vs. vitrified cycles"). Main outcome measures include survival, fertilization, embryo development and clinical outcome.


Condition Intervention Phase
Egg Banking
 Other: Vitrification of oocytes for IVF treatment
Other: Protocolary IVF treatment with fresh donor oocytes
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Impact of Egg-Banking in an Ovum-donation Program

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • To evaluate the clinical outcome in an ovum donation program conducted with egg-banking. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
Fresh donor oocytes
 Other: Protocolary IVF treatment with fresh donor oocytes
Experimental: Group I
vitrified donor oocytes
 Other: Vitrification of oocytes for IVF treatment

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Receptors

    • Women receiving donor oocytes and whose partners without seere pathology of semen.
    • BMI < 25

Donors:

Inclusion Criteria:

18 - 35 years oldaños.

  • Normal Response (8-15 follicles)to long protocol of ovarian stimulation with hCG
  • Donors with normal menstrual cycles ( 21-35 day duration).
  • Donors with Body Mass Index (BMI) between 18-25 Kg/m2

Exclusion Criteria:

  • Donors with +/= two previous miscarriages`
  • Polycystic Ovary Syndrome
  • Donors with antecedents of poor embrionary quality not attributed to masculine factor.
  • Donors with decline of Estradiol Hormone of more than 10% or Estradiol Hormone plateau.
  • Donors with a high response >20 ovocitos and/or levels above 3000pg/mL of Estradiol the day of the administration of Chorionic gonadotropin (hCG.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785993

Locations
Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Ana Cobo, PhD Instituto Valenciano de Infertilidad
  More Information

No publications provided by Instituto Valenciano de Infertilidad, Spain

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Ana Cobo, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT00785993     History of Changes
Other Study ID Numbers: 0703-C-017-AC
Study First Received: November 4, 2008
Last Updated: October 1, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Egg banking, clinical outcome

ClinicalTrials.gov processed this record on June 18, 2013